Real-World, Multinational ‘RESPONSE’ to Standard-of-Care Practices with PARP Inhibitors in Patients with Advanced Ovarian Cancer

2020 Year in Review - Ovarian Cancer

The RESPONSE study will help characterize patient characteristics and regional specific therapeutic management strategies adopted in 7 countries to better understand poly (ADP-ribose) polymerase (PARP) inhibitor use and its impact on outcomes.

Compelling evidence has been demonstrated in recent randomized clinical trials, highlighting the benefit of integrating PARP inhibitors and the combination of a PARP inhibitor + bevacizumab into the first-line treatment of select groups of patients with advanced-stage ovarian cancer.

The impact of PARP inhibitor treatment remains unclear, however, especially when translating clinical trial data into a real-world environment, where heterogeneous patient populations and variations in national clinical practices may affect the treatment potential of these agents.

At the European Society of Gynaecological Oncology 2020 Virtual Conference, Christian Marth and colleagues described therapeutic approaches and outcomes of advanced ovarian cancer, using observational data in a multinational trial to evaluate the percentage of patients eligible for first-line PARP inhibitor maintenance therapy, as well as for concomitant bevacizumab treatment.

For approximately 1000 patients with advanced ovarian cancer, this global study will use real-world data focused on diagnostic workup, standard of care, clinical outcomes, and treatment. Potential PARP inhibitor eligibility is defined as having no macroscopic residual disease (<1 cm) following upfront surgery and/or having a clinical complete response/partial response following completion of first-line chemotherapy according to the label.

Multiple centers in 7 countries throughout Europe and Israel are participating in this ongoing study. Based on the projected inclusion of 120 patients per site, investigators anticipate being able to deliver detailed estimates of local PARP inhibitor eligibility; ideally, the study will be adequately powered to detect any clinically meaningful differences in PARP inhibitor eligibility between any 2 countries. The investigators concluded that global, real-world data on ovarian cancer are scarce.

The RESPONSE study will add to the current body of evidence about factors influencing eligibility to receive first-line PARP inhibitor therapy or the combination of a PARP inhibitor + bevacizumab maintenance treatment; this will provide insight into management strategies for ovarian cancer and specific practice patterns used in 7 different countries. This will help characterize patient attributes through mapping and key factors in the first-line treatment pathway, such as timing and outcome of surgery, as well as concomitant bevacizumab treatment.

Source: Marth C, et al. Int J Gynecol Cancer. 2020;30(4_suppl). Abstract 405.

 

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